2024 RAC Medical Marketing Practice Exam With Answers (89 Solved Questions)
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RAC Practice Exam Latest Updated 2024 With Complete Solutions
You have modified your 510(k)-cleared device with a Special 510(k). In which case
would a Special 510(k) not be appropriate for the device? - You have changed the
primary mechanism of action.
Which Premarket Approval Application (PMA) supplements are NOT subject to user
fee exemption? - Real Time Supplement
A medical device company allows its sales force to maintain a product inventory in
the field. The device has an expiration date indicated on its labeling. A sales person
notes that one of his products has expired and contacts the headquarters office
for direction. He is told to return the product to the headquarter office for
replacement. The return of this product is considered as what type of recall? -
Not a recall—it is considered normal stock rotation
A company is developing an (unapproved) drug-device combination product but is
not sure to which center it should submit its marketing application. The company
should first submit - A Request for Designation to the Office of Combination
Products
A medical device company is developing a product with drug, biologic and device
components. The product and indication have not been previously classified by
FDA. What is the most appropriate regulatory pathway? - A Request for
Designation (RFD) should be sent to the Office of Combination Products (OCP) at
FDA to determine the primary mode of action (PMOA) and assign the agency with
primary jurisdiction.
You have modified your 510(k)-cleared device with a Special 510(k). In which case
would a Special 510(k) not be appropriate for the device? - You have changed the
primary mechanism of action.
Which Premarket Approval Application (PMA) supplements are NOT subject to user
fee exemption? - Real Time Supplement
A medical device company allows its sales force to maintain a product inventory in
the field. The device has an expiration date indicated on its labeling. A sales person
notes that one of his products has expired and contacts the headquarters office
for direction. He is told to return the product to the headquarter office for
replacement. The return of this product is considered as what type of recall? -
Not a recall—it is considered normal stock rotation
A company is developing an (unapproved) drug-device combination product but is
not sure to which center it should submit its marketing application. The company
should first submit - A Request for Designation to the Office of Combination
Products
A medical device company is developing a product with drug, biologic and device
components. The product and indication have not been previously classified by
FDA. What is the most appropriate regulatory pathway? - A Request for
Designation (RFD) should be sent to the Office of Combination Products (OCP) at
FDA to determine the primary mode of action (PMOA) and assign the agency with
primary jurisdiction.
FDA's Office of Generic Drugs (OGD) remains committed to the "first-in, first-
reviewed" review order for the reviewing original Abbreviated New Drug
Applications (ANDAs), amendments and supplements unless there is a specific
reason to expedite an application. What is NOT a specific reason to grant
expedited review? - Products that show evidence of safety and effectiveness in a
new subpopulation
A firm is preparing a 510(k), premarket notification to FDA for an in vitro
diagnostic test, a microhematocrit analyzer that, among other intended uses, can
determine the hematocrit of a blood donor prior to donation of a blood product.
The firm should address the 510(k) submission to: - CBER
Notice of Intent to Revoke license can be issued for the following reason, EXCEPT
A Unable to gain access to the manufacturing plant,
B Licensed product are no longer safe and effective
C Failure to report serious adverse event,
D Manufacturer fails to conform to applicable standards - C
What is the formal early collaboration meeting that was implemented through the
Food and Drug Modernization Act (FDAMA)? - Agreement Meeting
The Agreement Meeting is a formal meeting to agree upon the parameters of the
investigational plan. When a meeting
request is received by FDA, the meeting will be held within 30 days. The
agreements made at the meeting are provided in writing to the sponsor and are
binding on FDA. Regulatory Reference: Early Collaboration Meetings Under the FDA
Modernization Act; Final Guidance for Industry and for CDRH Staff (February 2001).
Which of the following is NOT required for compliance under 21 CFR Part 11
(electronic records and electronic signatures)?
A Manually generated timestamped audit trails to record the date and time of
operator entries and actions that create, modify or delete electronic records.
reviewed" review order for the reviewing original Abbreviated New Drug
Applications (ANDAs), amendments and supplements unless there is a specific
reason to expedite an application. What is NOT a specific reason to grant
expedited review? - Products that show evidence of safety and effectiveness in a
new subpopulation
A firm is preparing a 510(k), premarket notification to FDA for an in vitro
diagnostic test, a microhematocrit analyzer that, among other intended uses, can
determine the hematocrit of a blood donor prior to donation of a blood product.
The firm should address the 510(k) submission to: - CBER
Notice of Intent to Revoke license can be issued for the following reason, EXCEPT
A Unable to gain access to the manufacturing plant,
B Licensed product are no longer safe and effective
C Failure to report serious adverse event,
D Manufacturer fails to conform to applicable standards - C
What is the formal early collaboration meeting that was implemented through the
Food and Drug Modernization Act (FDAMA)? - Agreement Meeting
The Agreement Meeting is a formal meeting to agree upon the parameters of the
investigational plan. When a meeting
request is received by FDA, the meeting will be held within 30 days. The
agreements made at the meeting are provided in writing to the sponsor and are
binding on FDA. Regulatory Reference: Early Collaboration Meetings Under the FDA
Modernization Act; Final Guidance for Industry and for CDRH Staff (February 2001).
Which of the following is NOT required for compliance under 21 CFR Part 11
(electronic records and electronic signatures)?
A Manually generated timestamped audit trails to record the date and time of
operator entries and actions that create, modify or delete electronic records.
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